Activities of Chrysoula ZACHAROPOULOU related to 2020/0102(COD)
Plenary speeches (1)
Programme for the Union's action in the field of health for the period 2021-2027 (“EU4Health Programme”) (debate)
Opinions (1)
POSITION IN THE FORM OF AMENDMENTS on the proposal for a regulation of the European Parliament and of the Council on the establishment of a Programme for the Union's action in the field of health –for the period 2021-2027 and repealing Regulation (EU) No 282/2014 (“EU4Health Programme”)
Amendments (13)
Amendment 164 #
Proposal for a regulation
Recital 10
Recital 10
(10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage healthany future sanitary crisises, the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. Thise revision of Decision No 1082/2013/EU could includitiate strategic stockpiling of essential medical supplies, in addition to the reactive reserve created under RescEU during the Covid-19 pandemic, or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. This revision could also introduce the creation of a European Health Response Mechanism to respond to all types of health crises (infectious, chemical, environmental, biological, food, nuclear), to strengthen operational coordination at European level and to monitor the constitution and the triggering of the strategic reserve of medicines and medical equipment and ensure its proper functioning. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management and response capacity of actors at the Union, national, regional and local level, including contingency planning and preparedness exercises, in keeping with the “One Health” and “Health in all policies” approaches. It should facilitate the setting up of an integrated cross-cutting risk communication framework working in all phases of a health crisis - prevention, preparedness and response. __________________ 10Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 183 #
Proposal for a regulation
Recital 11
Recital 11
(11) As in the time of health crisis emergency health technology assessment as well as clinical trials can contribute to the rapid development of medical countermeasures the Programme should provide support to facilitate such actions. The Commission has adopted a proposal11 on Health Technology Assessment (HTA)TA to support cooperation on health technology assessment at Union level. The Council should adopt a common position and start the negotiations with the Parliament on this proposal. __________________ 11Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU, COM(2018) 51 final of 31.01. 2018.
Amendment 191 #
Proposal for a regulation
Recital 12
Recital 12
(12) With a view to protect people in vulnerable situpopulations, including those suffering from mental illnesses andchildren, elder people, socioeconomically disadvantaged people, women, LGBTI people, ethnic minorities, people affected by a physical or mental disability, those suffering from chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups, taking into account their specific health needs.
Amendment 210 #
Proposal for a regulation
Recital 14 b (new)
Recital 14 b (new)
(14b) The coordination between national health systems is essential to guarantee solidarity within the Union. Joint procurement, coordinated transfer of equipment, reserve and circulation of blood products and organs, transports of patients for cross-border care should be adequately anticipated.
Amendment 211 #
Proposal for a regulation
Recital 14 c (new)
Recital 14 c (new)
(14c) In addition to an increased budget, the EU Civil Protection Mechanism (UCPM) and its instrument RescEU should be strengthened to ensure a truly common, coordinated and effective response at EU level.
Amendment 213 #
Proposal for a regulation
Recital 14 e (new)
Recital 14 e (new)
(14e) European health agencies, in particular the ECDC and the EMA should be granted strengthened competences, resources and personnel to allow them to better and quicker carry out their duties efficiently to the benefit of European citizens. To anticipate any types of crises, the Commission should also evaluate the needs of the other European health agencies such as EFSA, ECHA and EU- OSHA. A stronger coordination between European Agencies should be guaranteed by the Commission.
Amendment 214 #
Proposal for a regulation
Recital 14 f (new)
Recital 14 f (new)
(14f) The Programme should support the revision of ECDC’s mandate to extend its competencies to the chronical diseases, to elaborate mandatory guidances for Member States and to be able to coordinate laboratory research in times of health crises.
Amendment 215 #
Proposal for a regulation
Recital 14 g (new)
Recital 14 g (new)
(14g) The programme should also support the revision of the EMA’s mandate to extend its competencies on clinical trial’s coordination and management of the shortages of medicines. EMA could therefore meet any future challenges such as monitoring and responding to shortages in coordination with the Member States. In the long term, EMA should be able to make conditional marketing authorizations upon guarantees of supply and accessibility from manufacturers. The reinforcement of the EMA’s personnel should enable the Agency to carry out inspections of production sites established in third countries.
Amendment 231 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) The programme should support innovations in the digitalization area that could bring concrete benefits to patients and healthcare professionals and provide cost-effective high-quality healthcare whilst reducing inequalities. Important steps could be taken in digital skills, both for healthcare professionals and patients training, especially in rural and sparsely populated areas.
Amendment 409 #
Proposal for a regulation
Recital 33
Recital 33
(33) Given the common agreed values of solidarity towards equitable and universal coverage of quality health services as a basis for the Union’s policies in this area and that the Union has a central role to play in accelerating progress on global health challenges19 , the Programme should support the Union’s contribution to international and global health initiatives with a view to improve health, address inequalitiesincluding sexual and reproductive health, address inequalities, in particular gender inequalities, and increase protection against global health threats. __________________ 19Council conclusions on the EU role in Global Health, 3011th Foreign Affairs Council meeting, Brussels, 10 May 2010.
Amendment 413 #
Proposal for a regulation
Recital 36
Recital 36
(36) Cooperation with third countries should be strengthened on the exchange of knowledge and best practices in health systems preparedness and response. The programme should help building a strong and effective partnership between the Union and Africa and prioritise health systems strengthening, universal access to health services and global health research and development in the framework of the EU-Africa Strategy.
Amendment 531 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4
Article 4 – paragraph 1 – point 4
(4) strengthen the effectiveness, accessibility, sustainability and resilience of health systems, including by supporting digital transformation, the uptake of digital tools and services, systemic reforms, implementation of new care models and to reach universal health coverage objective, encompassing access to sexual and reproductive health and rights, and address social inequalities in health, including gender inequalities;
Amendment 605 #
Proposal for a regulation
Article 4 – paragraph 1 – point 10
Article 4 – paragraph 1 – point 10
(10) support the Union’s contribution to international and global health initiatives., including access to sexual and reproductive health and services;